Ultrasonic

Main information

  • Trade name:
  • Ultrasonic dental surgical system handpiece tip
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ultrasonic dental surgical system handpiece tip
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218264
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218264

A-DEC Australia - Ultrasonic dental surgical system handpiece tip

ARTG entry for

Medical Device Included Class IIa

Sponsor

A-DEC Australia

Postal Address

PO Box 7421,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

7/12/2013

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

W & H Dentalwerk Burmoos GmbH

Ignaz-Glaser-Strasse 53

Burmoos, Burmoos, A-5111

Austria

Products

1. Ultrasonic dental surgical system handpiece tip

Product Type

Single Device Product

Effective date

7/12/2013

GMDN

47015 Ultrasonic dental surgical system handpiece tip

Intended purpose

A removable endpiece that is attached to an ultrasonic dental surgical system handpiece, and makes

contact with a patient to mechanically fragment and cut bone or soft tissue upon contact during dental

surgery. For the treatment of organic hard and soft tissue in dental surgery, implantology, maxillo-facial

surgery, endodontics and periodontics.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 11:09:29 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information